CFR section
21 CFR 1271.350(a)(2): Reporting
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart E-Additional Requirements for Establishments Described in § 1271.10
Key facts
| Citation | 21 CFR 1271.350(a)(2) |
|---|---|
| Section | Reporting |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart E-Additional Requirements for Establishments Described in § 1271.10 |
| Subchapter | 21 CFR L Other |
| Product types cited | Drugs, Other_Regulations |
| Regulation text (excerpt) | (2) You must submit each report on a Form FDA-3500A to the address in paragraph (a)(5) of this section within 15 calendar days of initial receipt of the information. |
At a glance
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- 1–9 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.